MAUDE Adverse Event Report: RESPIRONICS CALIFORNIA, INC PHILIPS RESPIRONICS; V60

Model Number V60

Device Problem Connection Problem (2900)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2019.Date of report: 18april2019.A follow-up report will be submitted once the investigation has been complete.

Event Description

The customer reported that they were unable to screw hose connector.There was no patient involvement.Event date not specified, estimate used.

Manufacturer Narrative

Date rec¿d by mfr: 11jul2019.The manufacturer¿s customer specialist confirmed the reported issue.The manifold was replaced.Failure analysis on the returned 02 transport manifold revealed that there were stripped screw threads on port b and port c.The determination could be made that the device failed to meet specifications.The device was not being used for treatment when the reported event occurred, and there is a relationship of the device to the reported problem.The damaged screw threads on port b and port c of the o2 transport manifold prevented the o2 hose to connect.Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.

• Brand Name: PHILIPS RESPIRONICS
• Type of Device: V60
• Manufacturer (Section D): RESPIRONICS CALIFORNIA, INC; 2271 cosmos court; carlsbad CA 92011
• MDR Report Key: 8529830
• MDR Text Key: 142516861
• Report Number: 2031642-2019-02303
• Device Sequence Number: 1
• Product Code: MNT
• UDI-Device Identifier: 00884838020054
• UDI-Public: (01)00884838020054
• Combination Product (y/n): N
• PMA/PMN Number: K082660
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 03/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: V60
• Device Catalogue Number: 1053617
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1